BS-EN-ISO-10993-1 Historical Revision Information
Biological evaluation of medical devices. Evaluation and testing within a risk management process

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What is BS EN ISO 10993-1:October 2009?

The main objective of BS EN ISO 10993-1 is to protect people from potential biological hazards that could arise from the use of medical instruments or medical technology. The standard contains a variety of guidelines that relate to the biological analysis and testing of medical devices, such as dental equipment and surgical implants. It has been compiled to test medical instruments within a risk management process – as part of the overall evaluation and development of each device.

How does it work?

The general principles set out in BS EN ISO 10993 were developed to help organisations or individuals to do a biological evaluation of medical equipment within a risk management process. The standard looks at the general classification of devices based on their nature and duration of contact with the body. It also explains the evaluation of existing and relevant data from all sources, before identifying information gaps. BS EN ISO 10993 also shares best practice recommendations to do a full assessment of the biological safety of medical instruments.

Who should buy it?

    Anyone responsible for the biological evaluation of medical equipment
    Manufacturers of medical instruments, dental equipment and implants
    Suppliers of medical equipment
    Risk assessors


Cytotoxicity tests;Compatibility;Contaminants;Medical technology;Bioassay;Clinical investigation instruments;Implants (surgical);Dental equipment;Biological hazards;Biological analysis and testing;Dental materials;Medical equipment;Medical instruments

To find similar documents by classification:

11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)

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Document Number

BS EN ISO 10993-1:2009

Revision Level




Publication Date

June 30, 2010


BS EN ISO 10993-1:2003

Page Count




International Equivalent

EN ISO 10993-1:2009;ISO 10993-1:2009

Committee Number